The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Model 6110b Dentaphor.
Device ID | K870118 |
510k Number | K870118 |
Device Name: | MODEL 6110B DENTAPHOR |
Classification | Tester, Pulp |
Applicant | LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
Contact | Coats, M.d. |
Correspondent | Coats, M.d. LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
Product Code | EAT |
CFR Regulation Number | 872.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-12 |
Decision Date | 1987-04-10 |